NCT05978063

Study to Evaluate the Efficacy and Safety of Oral Difelikefalin for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica

A 2-part, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Oral Difelikefalin for Moderate-to-Severe Pruritus in Adult Subjects With Notalgia Paresthetica

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 214 (actual)
• Sponsor: Cara Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a 2-part, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of twice-daily (BID) oral difelikefalin for moderate-to-severe pruritus in adult subjects with NP.

Detailed description

Part A of this study will evaluate the benefit-risk of 3 doses of difelikefalin compared to placebo. The dose with the best benefit-risk profile will be further evaluated in Part B. Part A of this study comprises a 28-day Screening Period, a 7-day Run-in Period, an 8-week Double-blind Treatment Period, a 2-week Treatment Discontinuation Period, and a Safety Follow-up Visit (14 days after the last dose of study treatment). Part B of this study will evaluate the efficacy, safety, and tolerability of oral difelikefalin. The dose of oral difelikefalin to be assessed in Part B will depend on the results of Part A. Part B of this study comprises a 28-day Screening Period, a 7-day Run-in Period, an 8-week Double-blind Treatment Period, up to a 52-week OLE Period, and a Safety Follow-up Visit. Subjects who participated in Part A of the study may not participate in Part B. All subjects will sign an informed consent form (ICF) and undergo screening for study eligibility.

Conditions

• Pruritus
• Notalgia Paresthetica

Interventions

Type	Name	Description
DRUG	difelikefalin 2.0 mg tablets	Oral difelikefalin 2.0 mg administered twice daily
DRUG	difelikefalin 1.0 mg tablets	Oral difelikefalin 1.0 mg administered twice daily
DRUG	difelikefalin 0.25 mg tablets	Oral difelikefalin 0.25 mg administered twice daily
DRUG	Placebo tablets	Oral Placebo administered twice daily

Timeline

• Start date: 2023-08-01
• Primary completion: 2024-04-22
• Completion: 2024-05-07
• First posted: 2023-08-07
• Last updated: 2024-06-21

Locations

58 sites across 5 countries: United States, Canada, Germany, Poland, Spain

Regulatory

• FDA-regulated drug study